Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial

Table 1 SPIRIT figure: showing time points for enrollment, interventions, and assessment

	Study period
	Enrollment	Allocation	Post-allocation				Close-out
Time point	At 4 weeks after birth	At 4 weeks after birth	At 36 weeks postmenstrual age	At 40 weeks postmenstrual age	At 12, 26 weeks corrected age	At 52 weeks corrected age	At 104 weeks corrected age
Enrollment:
Eligibility screen	X
Informed consent	X
Demographic data	X
Allocation		X
Intervention:
Hydrocortisone		X
Placebo		X
Assessments:
Baseline variables assessments	X	X
Primary outcome			X
Secondary outcomes:
Brain volume				X
Others			X
Long-term outcomes:
Neurodevelopmental impairment, hearing loss, and blindness							X
Number of readmissions						X
Weight, length, and head circumference				X	X	X	X
Behavioral problems, premature birth-related mortality							X

ISSN: 1745-6215